GXpeople are looking for a QARA Associate to join a Medical Device company in Surrey. Our client are an Employee Owned company where every team member has a say in how the company is run.
This is a full-time hybrid position, working 3 days in office, 2 from home
WHAT WILL YOU BE DOING?
* Contributing into the Quality and Regulatory Affairs department
* Maintaining Quality Management System certification to ISO13485
* Set up and execute internal audits as directed by Quality Management. Support on-site audits conducted by external providers.
* Evaluate audit findings and implement appropriate corrective actions.
* Maintaining CE Marking certification including maintaining product EU MDR technical files and managing audits from our Notified Body.
* Obtaining and maintaining international production registration including USA FDA, Canada, Australia, Brazil.
* Keeping up to date with changing regulations.
* Participating in Product Development evaluation and planning. Maintaining product modification records will be important
* Working closely with suppliers to ensure ongoing compliance.
* Training internal staff on our QA procedures – familiarity with Quality Assurance management software will be a distinct advantage
Personal requirements
Education and Experience
· Ideally 2 plus years experience in quality and / or regulatory affairs ideally in the medical device industry.
· A technical degr...